希维奥®(塞利尼索)
Search documents
德琪医药-B(06996.HK):希维奥在马来西亚获批用于治疗弥漫大B细胞淋巴瘤一种新适应症
Ge Long Hui A P P· 2025-12-16 22:42
Core Viewpoint - The approval of the supplemental new drug application (sNDA) for Hivio® (Selinexor) by the Malaysian National Pharmaceutical Regulatory Agency marks a significant advancement for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have undergone at least two lines of systemic therapy and are not eligible for autologous stem cell transplantation [1] Group 1 - The Malaysian National Pharmaceutical Regulatory Agency has approved the sNDA for Hivio® [1] - Hivio® is indicated for adult patients with relapsed or refractory DLBCL [1] - The approval is specifically for patients who have received at least two lines of systemic therapy and are not suitable for autologous stem cell transplantation [1]
德琪医药-B(06996)发布中期业绩,经调整期内亏损7285.8万元 同比减少52.25%
智通财经网· 2025-08-22 08:39
智通财经APP讯,德琪医药-B(06996)发布截至2025年6月30日止6个月中期业绩,该集团取得收入人民币 5318.2万元(单位下同),同比减少12.5%;研发成本7993.5万元,同比减少38.91%;经调整期内亏损7285.8 万元,同比减少52.25%;每股亏损0.12元。 我们的收入从截至2024年6月30日止6个月的6080万元减少760万元至截至2025年6月30日止6个月的5320 万元。于2023年12月,希维奥®(塞利尼索)成功获纳入2023年版国家医保目录,由于积极的市场预期, 初始推动了截至2024年6月30日止6个月的强劲市场增长。随后,市场需求逐渐恢复理性。值得注意的 是,我们截至2025年6月30日止6个月的收入较2024年下半年增加2200万元,反映收入的稳步增长与稳定 状况。 ...
德琪医药-B(06996.HK)上半年期内亏损收窄至7640万元
Ge Long Hui· 2025-08-22 08:38
Core Viewpoint - The company reported a decrease in revenue for the six months ending June 30, 2025, compared to the same period in 2024, but showed signs of recovery and growth in the latter half of 2025 [1] Financial Performance - Revenue decreased from RMB 60.8 million for the six months ending June 30, 2024, to RMB 53.2 million for the same period in 2025, a reduction of RMB 7.6 million [1] - The loss for the period decreased from RMB 167 million for the six months ending June 30, 2024, to RMB 76.4 million for the same period in 2025, a reduction of RMB 90.6 million [1] Market Dynamics - The inclusion of the drug Cevinostat (希维奥®) in the 2023 National Medical Insurance Directory in December 2023 initially drove strong market growth expectations for the six months ending June 30, 2024 [1] - Market demand gradually returned to a rational state after the initial surge [1] - Revenue for the six months ending June 30, 2025, increased by RMB 22 million compared to the second half of 2024, indicating steady growth and stability [1]